Regulatory Affairs Manager

Regulatory Affairs Manager

LivaNova

Saluggia, Italy

The Regulatory Affairs Manager, reporting directly to the Director Regulatory Affairs Cardiac Surgery, is responsible for managing and implementing the activities required to obtain and maintain regulatory clearance for the Company’s devices, which consist of implantable heart valves, annuloplasty rings and related accessories and instruments.

Main activities and responsibilities will be as follows:

  • Lead the local Regulatory Affairs team, including direct management of team members;
  • Supervise and coordinate activities intended to obtain and maintain the product registrations in EU and extra-EU Countries;
  • Assess the regulatory impact related to changes in the Company’s products, processes or labeling and supervise the preparation of technical documentation to inform the Regulatory Authorities of planned changes to the approved products;
  • Cooperate and maintain the relations with Vigilance Authorities, Notified Bodies and National Government Agencies, supervise and prepare periodic reports and notifications to Regulatory Authorities;
  • Participate on project teams to identify regulatory requirements, to ensure that regulatory strategies are communicated and that regulatory requirements are met;
  • Monitor and verify product documentation to ensure compliance with the applicable regulatory requirements;
  • Maintain strong business relationship with key internal customers (such as Quality Assurance, Operations and R&D) providing advice on regulations relevant for the Company and its products.

The ideal candidate should have:

  • Master Degree in Engineering or Sciences;
  • 5+ years of experience in Regulatory Affairs;
  • Excellent knowledge of regulations related to marketing authorization and distribution of medical devices in European Countries;
  • Proven leadership experience as employees’ manager or serving in a leadership role;
  • Excellent interpersonal, written and oral communication skills, ability to work in an international environment Strong organizational skills; rigorous and detail oriented; able to prioritize and multi-task;
  • Fluency in English is mandatory;
  • Nice to have: previous experience in implantable and cardiovascular devices.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

LivaNova     Italy     Clinical Research     Manager and Executive     Medical Devices     Regulatory Affairs     5 Years+ Experience    

© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies